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Transpalpebral Microcurrent Stimulation for the Improvement of Visual Acuity in Patients With Macular Degeneration

Primary Purpose

Age-Related Macular Degeneration, Nonexudative Age-related Macular Degeneration

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Active microcurrent therapy
Sponsored by
Jarding, John, OD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age-Related Macular Degeneration

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adults aged at least 50 years with dry AMD in at least one eye Exclusion Criteria: Eye diseases other than dry AMD Implanted electrical devices Seizure disorders

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Active microcurrent therapy

    Arm Description

    Outcomes

    Primary Outcome Measures

    Mean logMAR BCVA
    Mean logarithm of the minimum angle of resolution (logMAR) best-corrected visual acuity (BCVA) following the last treatment

    Secondary Outcome Measures

    Proportion of improved, stable or worsened BCVA
    Proportion of eyes with improved, stable or worsened BCVA, and BCVA with both eyes open

    Full Information

    First Posted
    January 20, 2023
    Last Updated
    January 28, 2023
    Sponsor
    Jarding, John, OD
    Collaborators
    Professor Timothy Jackson, King's College, i-Lumen Scientific, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05703867
    Brief Title
    Transpalpebral Microcurrent Stimulation for the Improvement of Visual Acuity in Patients With Macular Degeneration
    Official Title
    Interventional Study of Transpalpebral Microcurrent Stimulation for the Improvement of Visual Acuity in Patients With Macular Degeneration
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1998 (Actual)
    Primary Completion Date
    December 1999 (Actual)
    Study Completion Date
    December 1999 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Jarding, John, OD
    Collaborators
    Professor Timothy Jackson, King's College, i-Lumen Scientific, Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Device Product Not Approved or Cleared by U.S. FDA
    Yes
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The goal of this clinical trial is to evaluate the effectiveness of transpalpebral microcurrent stimulation as a therapy for dry age-related macular degeneration. Participants are assessed at baseline for visual acuity and treated for 4 consecutive days for a total of 8 sessions (2 per day) with microcurrent stimulation. A follow-up visit is conducted to evaluate the participant and collect follow-up visual acuity.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Age-Related Macular Degeneration, Nonexudative Age-related Macular Degeneration

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    404 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Active microcurrent therapy
    Arm Type
    Experimental
    Intervention Type
    Device
    Intervention Name(s)
    Active microcurrent therapy
    Intervention Description
    Non-invasive transpalpebral microcurrent therapy delivery to the upper and lower eyelids
    Primary Outcome Measure Information:
    Title
    Mean logMAR BCVA
    Description
    Mean logarithm of the minimum angle of resolution (logMAR) best-corrected visual acuity (BCVA) following the last treatment
    Time Frame
    Week 1
    Secondary Outcome Measure Information:
    Title
    Proportion of improved, stable or worsened BCVA
    Description
    Proportion of eyes with improved, stable or worsened BCVA, and BCVA with both eyes open
    Time Frame
    Week 1

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adults aged at least 50 years with dry AMD in at least one eye Exclusion Criteria: Eye diseases other than dry AMD Implanted electrical devices Seizure disorders

    12. IPD Sharing Statement

    Learn more about this trial

    Transpalpebral Microcurrent Stimulation for the Improvement of Visual Acuity in Patients With Macular Degeneration

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